Associate, QA Operation Support

United States·North BrunswickFull Timemid

OtherAssociate

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Overview

Job Description Date 7/2025 Location 1300 Airport Road, North Brunswick NJ Title Associate, QA Operation Support Department Quality Assurance Reports to Manager, QA Operations FLSA (Exempt or Non-Exempt Exempt Role Overview This position is one of high regulatory responsibility that…

Requirements Summary

Education & Qualification: Level 1 – Associate, QA Operations Support B.Sc. / B.Pharm. or equivalent in a science-related field. Relevant QA experience working within a GMP and/or with GCP regulations. Level 2 – Associate, QA Operations Support B.Sc.

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gcpmentoring

7/2025

1300 Airport Road, North Brunswick NJ

Associate, QA Operation Support

Quality Assurance

Manager, QA Operations

Exempt

This position is one of high regulatory responsibility that provides direct quality oversight for the cGMP production of Dietary Supplements and nutraceuticals. This position will help ensure compliance to SOPs, batch records, master manufacturing records, and to 21 CFR Part 111 and 117.

Responsibilities

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Responsibilities

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→Assist with material sampling and dispensing under guidance.
→Support line clearance and hygiene compliance checks.
→Label and transport sampled materials as per SOPs.
→Maintain basic records and area cleanliness.
→Learn cGMP and SOP requirements.

Requirements

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Responsibilities

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→Execute material sampling , releasing , dispensing as per approved procedures as needed.
→Perform line clearance and ensure area readiness.
→Label materials correctly and ensure segregation of sampled vs. un-sampled.
→Maintain logbooks, records, and data entries accurately.
→Report deviations or incidents to the coordinator promptly.

Responsibilities

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→Supervise and coordinate QA sampling releasing , dispensing as per approved procedures as needed.
→Review documentation completed by associates.
→Ensure timely and compliant execution of sampling plans.
→Conduct training and mentoring for junior staff.
→Support audits, investigations, and CAPA implementation.
→Performs issuance of batch cards of Manufacturing, Coating and Packaging.
→Collects samples from on floor production for further testing and retention.
→Distributes testing samples to In-house Analytical , Elemental and Microbiology Labs
→Prepares In process Labels for production ,and QA samples to be provided along with the Batch Records

Responsibilities

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Works in a safe and responsible manner in order to create an injury-free and incident-free workplace.
Complies with all job-related safety and other training requirements.
Keeps management informed of area activities and of any significant problems.

Requirements

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Requirements

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B.Sc. / B.Pharm. or equivalent in a science-related field.
Relevant QA experience working within a GMP and/or with GCP regulations.

B.Sc. / B.Pharm. (required)
1–3 years of experience in QA or related area preferred working within a GMP and/or with GCP regulations.

B.Sc. / B.Pharm. (minimum); M.Sc. / M.Pharm. preferred
3–6 years of relevant QA experience working within a GMP and/or with GCP regulations.

Willingness to learn and follow instructions.
Basic understanding of GMP (preferred).
Good observational and documentation skills.
Teamwork and adaptability.

Working knowledge of cGMP and SOPs.
Attention to detail and strong documentation habits.
Familiarity with quality systems (e.g., logbooks, traceability).
Communication and coordination abilities

Strong knowledge of cGMP and quality systems.
Leadership and team management skills.
Effective communication and problem-solving.
Ability to handle audits, deviations, and cross-functional coordination.
Good documentation and review capabilities.

Requirements

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Work is regularly performed inside a manufacturing environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employee can be exposed daily to chemicals and cleaning agents.

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all the job responsibilities, duties, skill, or working conditions. In addition, this document does not create an employment contract, implied or otherwise, other than an "at will" relationship.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, genetic information, disability, protected veteran status, or any other characteristic protected by applicable local, state, or federal law.